An interventional study of Exercise protocol in Cystic Fibrosis, Cystic Fibrosis in Children and Cystic Fibrosis Pulmonary Exacerbation, sponsored by Hospital de Clinicas de Porto Alegre. Status unknown at 1 site in Brazil. Open to participants aged 6 Years to 18 Years. Per ClinicalTrials.gov, last updated 2017-09-06.
Sponsored by Hospital de Clinicas de Porto Alegre · Not applicable, Interventional, and Treatment
Among 13 studies in Cystic Fibrosis with a site in Brazil — none open to participants now, none under way, none of them phase 3. Cystic Fibrosis · Brazil.
Among the 13 studies in Cystic Fibrosis with a site in Brazil, this one is the 4th largest by planned enrollment of the 12 interventional ones that give a count, is one of 2 that started in 2017, is one of 8 with no phase, and was the 11th registered.
1,619 studies on the registry are indexed under Cystic Fibrosis; 199 are open to participants now.
Browse Cystic Fibrosis studies →None of the 13 studies in Cystic Fibrosis with a site in Brazil is open now.
Of the 154 Cystic Fibrosis studies recruiting now, 95 (62%) set no upper age limit and 43 (28%) stop at 75 or younger; 84 take children under 18; 41 take healthy volunteers.
This study: 6 Years to 18 Years · all sexes · no healthy volunteers.
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13 studies; the count open now beside each. This study's row is marked.
First in 2005; this study’s year is marked. 2 started in 2017.
This study's planned enrollment of 50 is above the median of 36 across 1,051 interventional studies indexed under Cystic Fibrosis.
Median enrollment 20 across the 12 interventional studies, 55 across the 1 observational. Of the 9 that completed or were terminated, 2 (22%) have results posted.
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3 of 13 have an industry lead sponsor. The 8 most frequent:
Hospital de Clinicas de Porto Alegre is the lead sponsor of 456 studies on the registry; 61 are open to participants now.
Hospital de Clinicas de Porto Alegre has 3 studies filed under Cystic Fibrosis — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 13 studies in Cystic Fibrosis with a site in Brazil, from their registry updates:
Nothing recorded among them since 2026-09-25.
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The objective of this study was to evaluate the effect of a physical exercise program on the functional capacity of children and adolescents with cystic fibrosis hospitalized at the Hospital de Clínicas of Porto Alegre (HCPA) through a six-minute walk test using the distance traveled In six minutes.
In the first 48 hours of hospital stay, the following evaluations will be performed: Six-minute walk test, physical and health fitness test, spirometry and data collection. Patients will be randomized to either control group or intervention group. The control group will receive the conventional treatment offered by hospital care, the intervention group will receive this same treatment plus an exercise protocol. After 14 days they will be reevaluated with the same tests applied at the beginning of hospitalization.
The objective of the study is to evaluate the effect of a protocol of physical exercises on the functional capacity of children and adolescents with cystic fibrosis, hospitalized, in the stage of exacerbation of the disease.
In the first 48 hours of hospitalization patients and their caregivers will be invited to participate in the study. We will start with the following evaluations: Six-minute walk test, spirometry, physical fitness and health test (includes: walking, abdominal, flexibility and abdominal circumference), clinical score of shwachman kulczycki and Collected data from medical records.
After the initial evaluation the patient will be randomized to control group or intervention group. The control group will receive the conventional physiotherapy by the assistance team and the recreation service by the physical education. The intervention group will receive the same assistance plus the intervention with the exercise protocol five times a week supervised by a health professional. The exercise protocol includes: Punching, climbing and descending steps, sit and stand, push-ups on the wall, stationary gait, abdominal, physiotherapy bridge, jumping on the floor ladder, cycling on the cycle ergometer and stretching.
At hospital discharge both groups will repeat the initial tests. The hypothesis is that the intervention group showed an improvement in functional capacity compared to the control group.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients randomized to the control group will receive routine physiotherapeutic follow-up, performed by the physiotherapist of the hospital during the hospitalization period. Supervision includes inhalation therapy and respiratory physiotherapy. Respiratory exercises and thoracic maneuvers for bronchial hygiene will be performed, according to what the patient is accustomed to perform. Other techniques besides these can be added at the discretion of the physiotherapist according to the needs of the patient. In pediatric hospitalization patients also receive care from physical educators who associate recreational and recreational activities with the treatment.
Patients randomized to the intervention group, in addition to routine physical therapy follow-up, will receive a program of physical exercises, illustrated in the form of a booklet and guided by a health professional. The patient is instructed to perform physical exercises five times a week until a hospital discharge. The participant will receive with a booklet a diary to write down the days in which to carry out the proposed exercises, in case of fault he will write down the reason for not performing. The exercise protocol includes: Punching, climbing and descending steps, sit and stand, push-ups on the wall, stationary gait, abdominal, physiotherapy bridge, jumping on the floor ladder, cycling on the cycle ergometer and stretching.
Other: Exercise protocol
Protocol of exercises performed in hospital admission in children and adolescents with cystic fibrosis in the exacerbation phase.
Functional capacity
Evaluate the distance covered by the six-minute walk test
Time frame: 14 days
Pulmonary functional capacity
Spirometry
Time frame: 14 days
Physical fitness and health
Generate a score.
Time frame: 14 days
Clinical score Shwachman-Kulczycki
Scoring for general activity, physical examination, nutrition and radiological findings of the thorax.
Time frame: 14 days
bacteriology
The last bacteriological exams will be noted
Time frame: 14 days
Nutrition assessment
Body mass index
Time frame: 14 days
Started Aug 2017 (actual). Primary completion is estimated for Aug 2018, 12 months after the start.
Of 212 non-industry interventional studies with no phase under Cystic Fibrosis, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 48. This study's planned 12 months is below that.
Counting every sponsor, half of 227 studies reached it within 23 months; a quarter within 12 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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